Large intestinal blockages can be treated preoperatively and palliatively with a stent placed in the colon. To that end, researchers plan to look into what happens to colonic stents after they’ve been approved by the Food and Drug Administration (FDA). Post-release data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database were reviewed for the period of January 2011 through December 2020 as part of the post-marketing monitoring. About 691 device-related difficulties and 742 patient-related complications were documented throughout the study period. An increase from 6.40% in 2011 to 7.4% in 2020 was observed in the number of adverse occurrences. The most common cause of device problems was improper placement (n=201, 29%), followed by device breakage (n=60, 8.6%), delamination (n=41, 6.3%), and device migration/expulsion (n=38, 5.55%). Among the reports, there was a significant number (n=141, 20.3%) detailed an unclassified adverse event without identifying a device or operator issue. Perforation (n=150, 20.1%), mortality (n=47, 6.3%), stomach pain/discomfort (n=27, 3.6%), and peritonitis (n=24, 3.2%) were the most commonly reported adverse events among patients. When considering colonic stent implantation, endoscopists and referring doctors should be aware of the rare but critical patient and device problems highlighted by the MAUDE database.
- Business of Medicine
- Doctor’s Voice